Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT05644912
Eligibility Criteria:
Inclusion Criteria:
1. Provision of informed consent.
2. Female and male aged 18-80 years.
3. Patients successfully treated by TAI with Navina Smart system for at least 3 months and/or stable in therapy.
4. Patients considered suitable to participate by investigator.
5. Able to read, write and understand information given to them regarding the study.
Exclusion Criteria:
1. Involvement in the planning and conduct of the clinical investigation (applies to both Wellspect HealthCare staff and staff at the study site).
2. Previous enrolment in the present clinical investigation.
3. Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last month, that may interfere with the present clinical investigation.
4. Severe non-compliance to Clinical Investigation Plan as judged by the investigator and/or Wellspect HealthCare.
5. Significant cardiovascular and/or other significant co-morbidities which could be negatively affected by the use of the investigational product.
6. Known anal or colorectal stenosis.
7. Active inflammatory bowel disease.
8. Acute diverticulitis.
9. Colorectal cancer.
10. Ischemic colitis.
11. Any anal or colorectal surgery within the previous 3 months.
12. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.
13. Any condition, as judged by the investigator, which might make follow-up or investigations inappropriate.
14. Any patient that according to the Declaration of Helsinki is unsuitable for enrolment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05644912
Study Brief:
Protocol Section:
NCT05644912